Kornimate/medical-research-clean huggingface dataset:
setting up a blood bank for gene therapy in hiv-infected infants

Conditions: HIV Infections; Pregnancy

Summary: the purpose of this study is to set up a blood bank for infants who have hiv-positive mothers. this blood may be used in the future to treat the child if he/she turns out to be hiv-positive. blood from the umbilical cord contains a certain kind of cell called a stem cell. stem cells eventually turn into one of the many types of blood cells. if hiv infection can be prevented in these stem cells, then, when these stem cells are injected back into the infant, the new cells that develop will also be protected from hiv. this study will provide the blood needed to test whether this type of gene therapy is safe and effective.

gene therapy may provide a new therapeutic approach to pediatric aids. putting an hiv-resistant gene into umbilical cord blood stem cells and transplanting the cells back into the patient could lead to the production of cells that resist hiv infection. if a patient's cells could be engineered to be resistant to supporting the growth of hiv-1, the cells may have improved survival in the presence of hiv-1. to date, an umbilical cord blood bank for hiv-positive deliveries has not been established in the united states. this protocol establishes a repository of banked umbilical cord blood as a first step toward the potential application of gene therapy for the treatment of hiv-infected infants. hiv-infected mothers have about 20 ml of blood drawn to test for infectious diseases (e.g., hepatitis). at time of delivery maternal hiv viral load is measured. after delivery, about 60 ml of blood is collected from the umbilical cord; this blood is labeled and transferred to the umbilical cord blood bank for possible use in future gene therapy studies on the infant. at birth, infant hiv status and general health are assessed. if the infant is found to be hiv-infected, the mother may be approached about the infant's participation in a future gene therapy study. if the infant is not hiv-infected, the cord blood is stored for up to four years and is then released to the mother, or, with her consent, to the research community.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. exclusion criteria your child will not be eligible for this study if he/she: * is not expected to live more than 6 months. * weighs less than 3.3 pounds.

Keywords: gene therapy specimen handling blood banks fetal blood
the triad of nutrition, intestinal microbiota and rheumatoid arthritis (tasty)

Conditions: Diet Interventions

Summary: the main goal of this trial is to investigate whether a dietary intervention based on a typical mediterranean diet enriched with fermented foods (meddiet+) can impact gut microbiota and ra-related outcomes.

100 ra patients will be recruited at uls santa maria in lisbon, portugal, and randomly assigned to either the intervention (meddiet+) or the control group. the 12-week nutritional intervention will include a personalized dietary plan based on the meddiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. the control group will receive general recommendations for a healthy diet at baseline. the intervention's effects will be assessed by evaluating disease activity, functional status, quality of life, intestinal permeability, endotoxemia, inflammatory biomarkers, intestinal and oral microbiota, serum proteomics, and serum glycome profile characterisation.

Eligibility criteria:
inclusion criteria: * ra patients (acr/eular2010 criteria) * age \>18-years * disease duration \>1-year * active disease (das28 \> 2.6units) * on stable medication for 12 weeks * low/medium meddiet adherence (predimed\<10) * willing to comply with study protocol exclusion criteria: * prednisolone dose ≥ 7.5 mg/day * antibiotic therapy 4-weeks prior to baseline * persistent use of nsaid's * inflammatory or irritable bowel disease * celiac disease * chronic diarrhea * diabetes * other immune-mediated inflammatory diseases besides ra * major organ dysfunction * cancer diagnosed in the last five years * health conditions which may difficult participation (cognitive impairment/psychiatric disease) * pregnant or lactating individuals

Keywords: diet interventions rheumatoid arthritis
hhhfnc (heated humidified high-flow nasal cannula) versus ncpap for respiratory distress syndrome of prematurity

Conditions: Newborn Respiratory Distress Syndrome

Summary: preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate respiratory distress syndrome within 72 hrs from birth: 1) ncpap set at 4-6 cmh2o or 2) hhhfnc providing a flow 4-6 l/min. the aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (hhhfnc) versus a more common one (ncpap).

preterm infants are eligible to the study if they present mild to moderate respiratory distress syndrome (rds) defined by the following criteria: need of fio2 ( fraction of inspired oxygen) ≥0.30 to keep a target spo2 (periferal oxygen saturation) beetween 88-93% and/or silverman score ≥5. to confirm the diagnosis a chest xr is performed as routinarily in the ward before starting the respiratory support. they are randomly assigned to one of the treatment groups cited in "brief summary" by means of closed envelops. a block randomization is applided with a blok size of 4. the randomization is stratified per groups accoring to gestational age: from 29+0 to 32+6; from 33+0 to 34+6; from 35+0 to 36+6 weeks+days. once the treatment is started, for the group ncpap there is the possibility to switch to the mode "bi-pap" if: there are more than 4 episodes of apnoea per hour or more than 2 episodes requiring positive pressure ventilation or if deemed by clinicians for increased work of breathing assesed by the silverman score. for all the groups, if the fio2 requirement is persistently higher than 0.35-0.40 per target spo2 86-93% and/or dyspnoea defined by silverman score \> 6 after starting the respiratory support, newborns receive surfactant by "insure" technique, involving endotracheal intubation by direct laryngoscopic vision, endotracheal administration of surfactant (curosurf, chiesi pharmaceutics, parma, italy) 200 mg/kg and finally extubation. after the administration of surfactant, if fio2 requirement is persistently \>0.4 to keep spo2 86-93% or severe apnea episodes are present (apnea episodes \> 4/hr or \>2/hr requiring positive pressure ventilation) or at the blood gas (capillary or venous) paco2\>70 mmhg and ph\<7.20, newborns are intubated and mechanically ventilated. for all the newborns enrolled in the study, capillary or venous blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. further controls follow the routine of the ward. weaning is started decreasing hhhfnc flow by 1 lpm or ncpap pressure by 1 cmh2o pressure if infants are presenting fio2 \< 0.30 to target spo2 and minimal or no signs of respiratory effort. the respiratory support is discontinued for flow ≤ 2 lpm or pressure ≤ 2 cmh2o.

Eligibility criteria:
inclusion criteria: * inborn * parental consent exclusion criteria: * no parental consent * major congenital malformations * severe intra ventricular hemorrage diagnosed early after birth

Keywords: ncpap, high flow nasal cannula, pretem infants, nicu
exacerbations and their outcomes international (exacos international)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: observational, cross-sectional study with retrospective data collection from medical records. during the cross-sectional study visit, data will be captured through the use of electronic case report forms (ecrfs). as there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit. for understanding the burden of severe exacerbations of copd and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries

observational, cross-sectional study with retrospective data collection from medical records. during the cross-sectional study visit, data will be captured through the use of electronic case report forms (ecrfs). as there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit. for understanding the burden of severe exacerbations of copd and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries patients, treated by pulmonologists, with an investigator-confirmed diagnosis of copd for at least 5 years from the index date (the date that signed informed consent was obtained) and who meet all of the inclusion and none of the exclusion criteria

Eligibility criteria:
inclusion criteria: * patients will be included if they meet the following inclusion criteria: 1. have an investigator-confirmed diagnosis of copd of at least 5 years and are over the age of 40 years old; 2. are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit); 3. have copd-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data; 4. have signed a written informed consent form exclusion criteria: * patients will be excluded from participation if they meet any of the following exclusion criteria: 1. have a diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis. this is because differentiating deteriorations in symptoms/exacerbations in these individuals at attributing them to copd is impossible

Keywords: chronic obstructive pulmonary disease copd
anlotinib plus immune checkpoint inhibitors for lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study aims to explore the efficacy of anlotinib with or without immune checkpoint inhibitor in standard chemo-immunotherapy failed advanced nsclc.

this study aims to explore the efficacy of anlotinib with or without immune checkpoint inhibitor in standard chemo-immunotherapy failed advanced nsclc. the primary endpoint was pfs.

Eligibility criteria:
inclusion criteria: 1. understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. age ≥ 18 years. 3. histopathology or cytology confirmed lung cancer 4. failed from first line chemo-immunotherapy. 5. ecog 0-1. 6. predicted survival ≥ 12 weeks. 7. adequate bone marrow hematopoiesis and organ function 8. presence of measurable lesions according to recist 1.1. 9. subjects with stable brain metastases may be included in the study. exclusion criteria: 1. subjects who have received any of the following treatments must be excluded: * treatment with molecules such as egfr, vegfr antibodies within 4 weeks prior to the first dose of study drug. * have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose. * ongoing (or inability to discontinue) possibly potent cyp1a2, cyp3a inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose. 2. presence of spinal cord compression or meningeal metastasis. 3. history of other malignant tumors within 2 years. 4. adverse events (except alopecia of any degree) of ctcae \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose. 5. history of stroke or intracranial hemorrhage within 6 months prior to the first dose. 6. the presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator. 7. subjects with persistent or active infection, including but not limited to hepatitis b (hbv), hepatitis c (hcv), human immunodeficiency virus (hiv) and covid-19 infection. 8. heart-related diseases or abnormalities 9. past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy. 10. refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection. 11. live vaccine was given 2 weeks before the first medication. 12. women who are breastfeeding or pregnant. 13. hypersensitivity to the test drug and the ingredients. 14. other conditions assessed by the investigator to be unsuitable for participation in the study.

Keywords: anlotinib, immune checkpoint inhibitor, nsclc
safety and efficacy of oral fampridine-sr for the treatment of spasticity resulting from spinal cord injury

Conditions: Spinal Cord Injury; Muscle Spasticity

Summary: normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. in people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. as a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. fampridine-sr is an experimental drug that increases the ability of the nerve to conduct electrical impulses. this study will examine the effects of fampridine-sr on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. the study will also examine the possible risks of taking fampridine-sr.


Eligibility criteria:
inclusion criteria: * incomplete traumatic spinal cord injury (at least 18 months prior and stable for 6 months) * moderate to severe lower-limb spasticity * able to give informed consent and willing to comply with protocol exclusion criteria: * pregnancy * history of seizures * existing or history of frequent urinary tract infections * history of drug or alcohol abuse * allergy to pyridine-containing substances * received a botox injection 4 months prior to study * received an investigational drug within 30 days * previously treated with 4-aminopyridine (4-ap) * not on stable medication dosing in 3 weeks prior to study * abnormal ecg or laboratory value at screening

Keywords: spinal cord injury muscle spasticity
ocular surface syndrome post-lasik, outcomes of treatment with platelet rich plasma

Conditions: Dry Eye After LASIK-Laser in Situ Keratomileusis

Summary: to evaluate the efficacy of autologous platelet-rich plasma eye drops (e-prp) for the treatment of chronic ocular surface syndrome (oss) following laser in situ keratomileusis (lasik).

prospective interventional consecutive case series including 156 eyes of 80 patients affected by chronic post-lasik oss who were treated with autologous e-prp 6 times a day as monotherapy for 6 weeks. assessment after treatment with e-prp included: dry eye symptoms, change in corrected distance visual acuity (cdva), corneal fluorescein staining (cfs) and conjunctival hyperemia.

Eligibility criteria:
inclusion criteria: * adult patients suffering from moderate to severe dry eye syndrome for 6 months or more after conventional treatments with artificial tears following lasik. * tear break-up time (tbut) between 4 and 9 seconds. exclusion criteria: * ocular pathology needing topical treatments different than dry eye syndrome * trombocitopeny, associated pathologies to coagulation factors or any state of plaquets antiagregation (aas and other aines). * ocular tumours, corneal distrophies, history of ocular herpes. * pregnant or nursering women.

Keywords: dry eye prp autologous after lasik ocular surface
alpha-gal pork challenge

Conditions: Allergy;Food

Summary: this study is investigating the hypothesis that alpha-gal is responsible for the gastrointestinal symptoms that occur in some alpha-gal syndrome subjects following the consumption of mammalian meat. this will be tested by comparing symptoms and immune responses in subjects with alpha-gal syndrome following consumption of "wild-type" pork (which contains alpha-gal) versus consumption of a novel pork product which has been genetically modified to lack alpha-gal (galsafe pork from revivicor inc.).


Eligibility criteria:
inclusion criteria: alpha-gal cases: * age 18-70 * patient report of episodic gi symptoms within past 6 months that correlated with ingestion of mammalian meat and/or dairy and which improved on a mammalian avoidance diet. * ige to α-gal \>0.1 iu/ml at screening visit. * willingness and ability to comply with scheduled visits and study procedures. control subjects: * age 18-70 * regularly consume/tolerate mammalian meat without obvious associated gastrointestinal or skin symptoms. * have eaten mammalian meat within the past 2 weeks * willingness and ability to comply with scheduled visits and study procedures. exclusion criteria: alpha-gal cases: * history of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the pi. * ige to pork which exceeds the value of ige to α-gal on screening test * unexplained, persistent urticaria or pruritis. * pregnancy, breastfeeding or lack of birth control in women of child-bearing age. * at the discretion of the principal investigator, patients may be excluded due to poorly controlled chronic gastrointestinal conditions including but not limited inflammatory bowel disease (i.e., crohn's disease, ulcerative colitis, microscopic colitis), acid reflux/heartburn, history of bariatric surgery or gastric banding, active peptic ulcer disease or any abdominal surgery within the past 2 months. * patient is unable to swallow food or has poor peripheral access. * patient has any medical or physiological disorder or condition that, in the opinion of the investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements. control subjects: * history of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the pi * unexplained, persistent urticaria or pruritis. * poorly controlled chronic gastrointestinal problem * patient is unable to swallow food or has poor peripheral access * patient has any medical or physiological disorder or condition that, in the opinion of the investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements.
clinical trial of sodium nitrite for out of hospital cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: in this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in seattle/king county will be enrolled. this will be a randomized clinical trial and patients will receive either two different doses of iv sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. the primary outcome will be proportion of patients surviving to hospital admission.

the hemodynamic effects of the optimal dose of iv nitrite administered in patients with cardiac arrest are unknown. a significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. in seattle/king county, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have return of spontaneous circulation (rosc) and are admitted to the hospital. in this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg iv (n=500) or 60 mg dose (n=500) of sodium nitrite. the study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). the investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy. patients will be eligible for this study if: 1. intravenous access (iv)/intraosseous access(io) 2. cardiac arrest, either ventricular fibrillation (vf) or non-vf patients receiving advanced cardiac life support (acls) by seattle/king county paramedics. 3. age 18 years or older 4. comatose exclusion criteria 1. traumatic cause of cardiac arrest 2. prisoner, pregnancy, age less than 18 (special population/vulnerable population) 3. known dnar 4. drowning as cause of arrest.

Eligibility criteria:
inclusion criteria: * cardiac arrest, either vf or non-vf, patients receiving acls by paramedics * iv or io access * comatose exclusion criteria: * traumatic cause of cardiac arrest * prisoner, pregnancy * known dnar
efficacy and safety of thr-4109 in obese subjects

Conditions: Obesity

Summary: the purpose of this study is to evaluate the safety and effect of thr-4109 on weight loss in obese subjects over a 24-week treatment period.


Eligibility criteria:
inclusion criteria: * 30 to 60 years of age * body mass index between 30 and 40 kg/m2 * women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study * able and willing to give written informed consent exclusion criteria: * weight loss of more than 3 kg in the previous 3 months * current or previous use (within 3 months) of medications that influence weight * known endocrine origin for obesity, such as hypothyroidism and cushing's syndrome * current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse * current serious/unstable medical condition * current pharmacologically treated diabetes or fasting plasma glucose ≥ 126 mg/dl

Keywords: obesity weight loss